Clinical Trial

Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment

Completed Phase 1
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Summary
This study evaluates the bioequivalence and adhesion performance of a test rivastigmine transdermal patch compared with the reference product, Exelon® Patch 10 (9.5 mg/24 h), in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation. Patch adhesion will also be evaluated throughout the dosing interval to determine whether the test product shows high adhesion (\>90%) or non-inferior adhesion compared with the reference product.
Trial Details
NCT Number NCT07464340
Lead Sponsor Zodiac Produtos Farmaceuticos S.A.
Conditions Bioequivalence Study in Healthy Subjects
Enrollment 68 participants
Start Date 2023-05-12
Primary Completion 2023-06-06 (estimated)
Study Completion 2023-07-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-11